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Chronic Lymphocytic LeukemiaPhase 1NCT03833180

A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Hematologic Malignancies (MK-2140-001)

A Phase 1 study testing Zilovertamab vedotin in people with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, run by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, pharmacokinetics, immunogenicity, and efficacy of zilovertamab vedotin given intravenously (IV) across a range of dose levels in participants with previously treated hematological cancers including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zilovertamab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
14 sitesUnited States
Study dates
14 Mar 2019to 18 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men or women of age ≥18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Histological diagnosis of CLL/SLL, MCL, FL, MZL, DLBCL, RTL, BL, LPL/WM, T-cell NHL, ALL, or AML as documented in medical records.
  • Hematological cancer under study has been previously treated and has progressed during or relapsed after prior systemic therapy.
  • Hematological cancer is unlikely to be responsive to established therapies known to provide clinical benefit or the study candidate has developed an intolerance to established therapies known to provide clinical benefit.
  • Presence of measurable cancer including CLL/SLL, MCL, FL, MZL, DLBCL, RTL, BL, LPL/WM, T-cell NHL, ALL, and AML.
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  • Current medical need for therapy due to disease-related symptoms or complications, cytopenias, lymphadenopathy, organomegaly, extranodal organ involvement, or progressive disease.
  • Availability of pretreatment tumor tissue.
  • Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study therapy.
  • All acute toxic effects of any prior antitumor therapy (not including hydroxyurea, cytarabine, and/or cyclophosphamide used in subjects with acute leukemia) resolved to ≤Grade 1 before the start of study therapy (with the exception of alopecia [Grade 1 or 2 permitted] or selected laboratory parameters [Grade 1 or Grade 2 permitted with exceptions.
  • Adequate bone marrow function.
  • Adequate hepatic profile.
  • Adequate renal function.
  • Adequate coagulation profile.
  • Negative antiviral serology.
  • For female participants of childbearing potential, a negative serum pregnancy test.
  • For both male and female participants, willingness to use protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.
  • Willingness and ability of the participant to comply with study activities.
  • Evidence of a personally signed informed consent document.
  • Previous treatment with an MMAE-containing drug is allowed.

Who cannot join

  • Presence of malignancy involving the central nervous system.
  • Presence of another cancer with disease manifestations or therapy that could adversely affect participant safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.
  • Significant cardiovascular disease within 3 months prior to start of study therapy.
  • Significant screening electrocardiogram (ECG) abnormalities.
  • Uncontrolled ongoing systemic bacterial, fungal, or viral infection.
  • Known diagnosis of liver cirrhosis.
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  • Pregnancy or breastfeeding.
  • Candidacy for hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR)-T-cell therapy with access to HSCT or CAR-T cells and a willingness to undergo such therapy.
  • In participants with prior HSCT, evidence of graft-versus-host disease (GVHD) with Grade ≥2 serum bilirubin, Grade ≥3 skin involvement, or Grade ≥3 diarrhea.
  • Prior solid organ transplantation.
  • Major surgery within 4 weeks before the start of study therapy.
  • Prior therapy with a receptor tyrosine kinase-like orphan receptor 1 (ROR1)-directed therapy.
  • Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks prior to Cycle 1 Day 1 (C1D1). If corticosteroid treatment is required for lymphoma symptom control prior to C1D1, up to 100 mg per day of prednisone equivalent can be given for up to 5 days. In that case, all tumor assessments must have been completed prior to the start of corticosteroid treatment.
  • Use of a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4.
  • Use within 7 days prior to the start of study therapy of a drug known to prolong the QT interval.
  • Concurrent participation in another therapeutic or imaging clinical trial.
  • Presence of a medical condition that (in the judgement of the investigator) interferes with the ability of the participant to participate in the study.
  • Has baseline peripheral neuropathy >Grade 1.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • University of Virginia Cancer Center ( Site 0012)

    Charlottesville, Virginia, 22908

  • City of Hope ( Site 0010)

    Duarte, California, 91010

  • MD Anderson Cancer Center ( Site 0001)

    Houston, Texas, 77030

  • MD Anderson Cancer Center ( Site 0011)

    Houston, Texas, 77030

  • University of California - San Diego ( Site 0003)

    La Jolla, California, 92093

  • UCLA Hematology & Oncology ( Site 0007)

    Los Angeles, California, 90095

  • Northwell Health ( Site 0009)

    New Hyde Park, New York, 11042

  • Weill Cornell Medical College ( Site 0005)

    New York, New York, 10021

  • Memorial Sloan Kettering Cancer Center ( Site 0014)

    New York, New York, 10065

  • University of Nebraska Medical Center ( Site 0006)

    Omaha, Nebraska, 68198-5331

  • Oregon Health & Science University ( Site 0004)

    Portland, Oregon, 97239

  • University of Rochester ( Site 0008)

    Rochester, New York, 14642

  • Swedish Medical Center ( Site 0002)

    Seattle, Washington, 98104

  • Memorial Sloan-Kettering Cancer Center ( Site 0019)

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation and Cohort-Expansion Study of VLS-101 in Subjects With Hematological Malignancies (waveLINE-001)

The purpose of this study is to evaluate the safety, pharmacokinetics, immunogenicity, and efficacy of zilovertamab vedotin given intravenously (IV) across a range of dose levels in participants with previously treated hematological cancers including acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), Burkitt lymphoma (BL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), Richter transformation lymphoma (RTL), and T-cell non-Hodgkin lymphoma (NHL).

Being tested
Zilovertamab vedotin
Keywords
Lymphoma, Lymphoma, Non-Hodgkin, Leukemia, B-Cell, Leukemia, Lymphoid, Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Burkitt Lymphoma, Lymphoma, Lymphoplasmacytoid, Waldenström Macroglobulinemia, Lymphoma, T-cell, Leukemia, Lymphoid, Acute, Leukemia, Myeloid, Acute
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma, Waldenstrom Macroglobulinemia, Lymphoma, T-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Zilovertamab vedotinDrug

    Also called VLS-101, MK-2140

    Zilovertamab vedotin administered via IV infusion per Schedule 1, 2, or 3 according to participant allocation.

Study groups in NCT03833180
Study groupRoleWhat they receive
Zilovertamab vedotin Schedule 1: Q1/3WExperimentalParticipants will be administered escalating doses of zilovertamab vedotin at 0.50, 1.00, 1.50, 2.25, 2.50, 2.75, and 3.00 mg/kg IV on Day 1 of repeated 21-day cycles (Q1/3W).
Receives: Drug: Zilovertamab vedotin
Zilovertamab vedotin Schedule 2: Q2/3WExperimentalParticipants will be administered escalating doses of zilovertamab vedotin at 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, and 2.25 mg/kg IV on Day 1 and 8 of repeated 21-day cycles (Q2/3W).
Receives: Drug: Zilovertamab vedotin
Zilovertamab vedotin Schedule 3: Q3/4WExperimentalParticipants will be administered escalating doses of zilovertamab vedotin at 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, and 2.25 mg/kg IV on Day 1, 8, and 15 of repeated 21-day cycles (Q3/4W).
Receives: Drug: Zilovertamab vedotin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of zilovertamab vedotin

    Participants will receive zilovertamab vedotin according to Schedule 1, 2, or 3. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD will be defined as the highest tested dose level at which ≥6 participants have been treated and which is associated with a Cycle 1 DLT in ≤17% of the participants.

    Measured: Cycle 1 (Up to 21 Days)

  2. Recommended Dosing Regimen (RDR)

    Selection of the RDR will be based on consideration of short- and long-term safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RDR may be the MTD or may be a lower dose within the tolerable dose range.

    Measured: Cycle 1 (Up to 21 Days)

Secondary outcomes (37)

  1. Average number of zilovertamab vedotin infusions administered

    Zilovertamab vedotin drug administration will be assessed by prescribing records and the average number of zilovertamab vedotin infusions administered will be determined.

    Measured: Up to 5 months

  2. Number of participants with a treatment-emergent adverse event (TEAE)

    An AE is any untoward medical occurrence in a participant administered a medicinal product; the event does not necessarily have a causal relationship with study drug administration or usage. Laboratory abnormalities, vital sign/oxygen saturation abnormalities, and adverse electrocardiogram (ECG) findings will also be recorded as AEs. A TEAE is defined as an AE that occurs or worsens in the period from the first dose of study drug administration to 30 days after the final dose of study drug administration. The number of participants with a TEAE will be reported for each arm.

    Measured: Up to approximately 3.5 years

  3. Number of participants with a DLT

    A DLT is defined as a protocol pre-specified TEAE that occurs in Cycle 1 of zilovertamab vedotin therapy and is considered drug-related. Failure to recover to baseline by ≥21 days from the last dose of study drug in the current cycle due to a drug-related TEAE is also considered a DLT. The number of participants with a DLT will be reported for each arm.

    Measured: Cycle 1 (Up to 21 Days)

  4. Number of participants with a serious adverse event (SAE)

    An SAE is defined as an untoward medical occurrence that results in any of the following outcomes: death, life-threatening situation, in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or other medically significant event.

    Measured: Up to approximately 3.5 years

  5. Number of participants with an adverse event of special interest (AESI)

    Prespecified AESIs for this study will include: Grade ≥3 infusion reactions, tumor lysis syndrome (TLS) of any grade, and Grade ≥3 peripheral neuropathy. The number of participants with an AESI will be reported for each arm.

    Measured: Up to approximately 3.5 years

  6. Number of participants that discontinue study treatment due to an AE

    An AE is any untoward medical occurrence in a participant administered a medicinal product; the event does not necessarily have a causal relationship with study drug administration or usage. The number of participants that discontinue study treatment due to an AE will be reported for each arm.

    Measured: Up to approximately 3.5 years

  7. Number of participants that use supportive care or concomitant medications

    The number of participants that use supportive care or concomitant medications will be reported for each arm.

    Measured: Up to approximately 3.5 years

  8. Plasma concentration of zilovertamab vedotin

    Plasma concentration of zilovertamab vedotin will be reported for each arm.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  9. Plasma concentration of total UC-961 antibody

    Plasma concentration of total UC-961 antibody will be reported for each arm.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  10. Plasma concentration of monomethyl auristatin E (MMAE)

    Plasma concentration of MMAE will be reported for each arm.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  11. Maximum plasma concentration (Cmax) of zilovertamab vedotin

    Blood samples collected predose and at multiple timepoints postdose will be used to determine Cmax of zilovertamab vedotin.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  12. Time to maximum plasma concentration (Tmax) of zilovertamab vedotin

    Blood samples collected predose and at multiple timepoints postdose will be used to determine Tmax of zilovertamab vedotin.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  13. Area under the plasma concentration time curve (AUC) of zilovertamab vedotin

    Blood samples collected predose and at multiple timepoints postdose will be used to determine AUC of zilovertamab vedotin.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  14. Volume of distribution (Vd) of zilovertamab vedotin

    Blood samples collected predose and at multiple timepoints postdose will be used to determine Vd of zilovertamab vedotin.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  15. Clearance (CL) of zilovertamab vedotin

    Blood samples collected predose and at multiple timepoints postdose will be used to determine CL of zilovertamab vedotin.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  16. Apparent terminal half-life (t½) of plasma concentration of zilovertamab vedotin

    Blood samples collected predose and at multiple timepoints postdose will be used to determine t1/2 of plasma concentration of zilovertamab vedotin.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  17. Cmax of total UC-961 antibody

    Blood samples collected predose and at multiple timepoints postdose will be used to determine Cmax of total UC-961 antibody.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  18. Tmax of total UC-961 antibody

    Blood samples collected predose and at multiple timepoints postdose will be used to determine Tmax of total UC-961 antibody.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  19. AUC of total UC-961 antibody

    Blood samples collected predose and at multiple timepoints postdose will be used to determine AUC of total UC-961 antibody.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  20. Vd of total UC-961 antibody

    Blood samples collected predose and at multiple timepoints postdose will be used to determine Vd of total UC-961 antibody.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  21. CL of total UC-961 antibody

    Blood samples collected predose and at multiple timepoints postdose will be used to determine CL of total UC-961 antibody.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  22. t1/2 of plasma concentration of total UC-961 antibody

    Blood samples collected predose and at multiple timepoints postdose will be used to determine t1/2 of plasma concentration of total UC-961 antibody.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  23. Cmax of MMAE

    Blood samples collected predose and at multiple timepoints postdose will be used to determine Cmax of MMAE.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  24. Tmax of MMAE

    Blood samples collected predose and at multiple timepoints postdose will be used to determine Tmax of MMAE.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  25. AUC of MMAE

    Blood samples collected predose and at multiple timepoints postdose will be used to determine AUC of MMAE.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  26. Vd of MMAE

    Blood samples collected predose and at multiple timepoints postdose will be used to determine Vd of MMAE.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  27. CL of MMAE

    Blood samples collected predose and at multiple timepoints postdose will be used to determine CL of MMAE.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  28. t1/2 of plasma concentration of MMAE

    Blood samples collected predose and at multiple timepoints postdose will be used to determine t1/2 of plasma concentration of MMAE.

    Measured: Cycle 1 Day 1, 2, 3, 8, 15: predose, end of infusion (up to 4 hours); Day 1, Day 8 (Schedule 2, 3), Day 15 (Schedule 3) of Cycles 2 through end of therapy (up to ~3.5 years): predose, end of infusion

  29. Number of participants with zilovertamab vedotin-reactive antibodies

    Number of participants with zilovertamab vedotin-reactive antibodies will be assessed.

    Measured: Day 1 of Cycles 1 through end of therapy (up to approximately 3.5 years): predose and end of infusion (up to ~30 minutes)

  30. Overall Response (OR)

    OR will be defined by achievement of the following outcomes as indicated by disease type: CLL/SLL: Complete response (CR: disappearance of detectable disease per Cheson 2012 criteria), CR with incomplete blood count recovery (CRi: CR with ≥1 additional change in absolute neutrophil count, platelet count, or hemoglobin), partial response (PR: no evidence of new disease per Cheson 2012 criteria), or PR with lymphocytosis (PR except lack of decrease in peripheral blood absolute lymphocyte count); NHL: CR (disappearance of all detectable disease per Cheson 2014 criteria) or PR (≥50% decrease in the sum of the product of diameters of the index nodal and extranodal lesions); LPL/WM: CR, very good PR (CR with ≥90% decrease in M protein), PR, or minor response (criteria for PR or stable disease met per Cheson 2014); ALL: (CR, CRi, unconfirmed CR, or PR per National Comprehensive Cancer Network criteria); AML (CR, CRi, morphologic leukemia-free state [MLFS], or PR per Cheson 2003 criteria).

    Measured: Up to approximately 3.5 years

  31. Complete Response without measurable residual disease (CRMRD-)

    CRMRD- is defined as the achievement of ≤1 × 10^-4 malignant cells in bone marrow (as assessed by flow cytometry) in a participant who meets all other criteria for CR.

    Measured: Up to approximately 3.5 years

  32. Percent change from baseline in tumor dimension

    Percent change in tumor dimensions is defined as the percent change from baseline in the sum of the products of the diameters (SPD) of index lesions.

    Measured: Up to approximately 3.5 years

  33. Time to Response (TTR)

    TTR is defined as the interval from the start of study therapy to the first documentation of an objective response.

    Measured: Up to approximately 3.5 years

  34. Duration of Response (DOR)

    DOR is defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression/relapse or death from any cause.

    Measured: Up to approximately 3.5 years

  35. Progression free survival (PFS)

    PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause.

    Measured: Up to approximately 3.5 years

  36. Time to Treatment Failure (TTF)

    TTF failure is defined as the interval from start of study therapy to the earliest of the first documentation of disease progression/relapse, treatment failure (for participants with ALL or AML), the permanent cessation of study drug due to an AE, or death from any cause.

    Measured: Up to approximately 3.5 years

  37. Overall Survival (OS)

    OS is defined as the interval from the start of study therapy to death from any cause.

    Measured: Up to approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2019
  2. Study start14 Mar 2019
  3. Primary completion18 Dec 2023
  4. Study completion18 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Cohorts of 3 to 6 subjects will be sequentially enrolled at progressively higher dose levels within each dose schedule of zilovertamab vedotin using a 3+3 dose-escalation design.
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03833180
Sponsor's protocol ID
2140-001
Other IDs
VLS-101-0001
Status last verified
Jan 2024
First submitted
4 Feb 2019
Last updated
12 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Wang ML, Barrientos JC, Furman RR, Mei M, Barr PM, Choi MY, de Vos S, Kallam A, Patel K, Kipps TJ, Rule S, Flanders K, Jessen KA, Ren H, Riebling PC, Graham P, King L, Thurston AW, Sun M, Schmidt EM, Lannutti BJ, Johnson DM, Miller LL, Spurgeon SE. Zilovertamab Vedotin Targeting of ROR1 as Therapy for Lymphoid Cancers. NEJM Evid. 2022 Jan;1(1):EVIDoa2100001. doi: 10.1056/EVIDoa2100001. Epub 2021 Oct 12.

    PubMed 38319241

  • Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.

    PubMed 34398557

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Zilovertamab vedotin in people with Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma, run by VelosBio Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of zilovertamab vedotin (time frame: Cycle 1 (Up to 21 Days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03833180, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.

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